Lyophilization is a process of vacuum-drying at low temperature of a previously frozen liquid that makes it possible to remove water in order to make it stable and therefore to preserve it; lyophilization is also called freeze-drying (“freeze drying” dryi

Computerized systems are subject to constant attention from the pharmaceutical companies that have, for the most part, developed a policy and appropriate procedures in the selection

There are several methods of sterilization of medical devices. The most common are the steam (or autoclave), ionizing radiations and ethylene oxide.

Lean approaches in validation are nothing new in our industry, methods in ‘streamlining (as it used to be termed)’ have been around since the early ‘90s and conceptualised in trade publications as early as the late ‘80s.

Printing labels for pharmaceutical industry require a production process with no-fault quality insurance moreover when labels are dedicated for injection drugs.

The new regulations and the effectiveness of pharmacovigilance put pressure on pharmaceutical packaging, leading to the proliferation of checkpoints on the packaging lines...

The instrument, IMD, has the capability of detecting the presence of bacteria and fungi in the environmental air. Its intended application is for environmental monitoring in a pharmaceutical facility.

One of the fundamental criteria of quality products is clean and sterile particulate and microbiological purity. The latter depends directly on the control of environmental conditions of their manufacture.

Is there a negative impact on the bioburden related to the use of non aseptic pre-filtration devices?

Good Manufacturing Practices (GMP) require that manufacturers can demonstrate and verify the on-going compliance of their suppliers.